Clinical Operations Manager - Regulatory

Job Description

Job Description

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

This role is accountable for performance and compliance for assigned protocols within US COuntry Operations in compliance with ICH/GCP (International Committee on Harmonization/Good Clinical Practice) and country regulations, our company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM (Senior Clinical Operations Manager) or CRD (Clinical Research Director), the person is responsible for ICF negotiations, IRB Submissions/Approvals and driving Site Ready activities.

Responsibilities include, but are not limited to:

• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC (Institutional Review Board/Ethics Committee) and the Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country.
• Contributes to the development of local SOPs (Standard Operating Procedures). Oversees CTCs (Clinical Trial Coordinator) as applicable.
• Coordinates and liaises with CRM (Clinical Research Manager), CTC, CRA (Clinical Research Associate), (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs (Clinical Trial Research Agreement) and local milestones. Collaborates closely with headquarter to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.
• Enters and updates country information in clinical systems.
• The position has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up.
• Works in partnership internally with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ (Headquarters) functional areas and externally with vendors and sites, IRB/IECs and Regulatory
• Authorities in submission and approval related-interactions.

Core competencies:

• The expertise of core clinical research systems (ie CTMS, eTMF) and metrics
• Strong coordination and organizational skills
• Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the Sr. COM or manager.
• Ability to make decisions independently with limited oversight from Sr. COM or manager.
• Requires a strong understanding of the local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Behavioral Competency Expectations:

• Problem-solving is essential to this position.
• Requires the ability to proactively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and4) issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• The ability to focus on multiple deliverables and protocols simultaneously is essential. It requires that the individual has the ability to work effectively also in a remote virtual environment with a wide range of people.

Experience Requirements:

• 5 years of experience in clinical research

Educational Requirements:

• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R58024